Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of gsk1120212, a mek inhibitor, in subjects with uveal melanoma

Conditions: GNA11 Mutation-positive Metastatic Melanoma; GNAQ Mutation-positive Metastatic Melanoma; Cancer; Metastatic Uveal Melanoma

Summary: the purpose of this study is to determine whether gsk1120212, a mek inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive gnaq or gna11 metastatic melanoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive gnaq or gna11 metastatic melanoma not previously treated with a mek inhibitor. * provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment. * the patient has a radiographically measurable tumor. * ecog performance status 0, 1, or 2. * the patient is able to swallow and retain oral medication. * life expectancy of at least 4 months. * toxicities from previous anti-cancer therapy (except alopecia) are recovered (grade 1 or less) at the time of enrollment. * the patient has adequate organ and bone marrow function. * sexually active patients must use medically acceptable methods of contraception during the course of the study. * female patients of childbearing potential must have a negative serum pregnancy test at screening. exclusion criteria: * the patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization. * the patient has received experimental therapy within 21 days of starting study drug. * the patient has received nitrosourea or mitomycin c within 42 days of starting study drug. * the patient has received any herbal medications or palliative radiotherapy within 14 days of starting study drug. * the patient is currently receiving anticoagulation therapy that is not well controlled. * ongoing or newly diagnosed eye abnormality other than symptoms due to uveal melanoma. * history of retinal vein occlusion or central serous retinopathy. * current severe, uncontrolled systemic disease. * history of leptomeningeal disease or spinal cord compression secondary to metastasis. * brain metastasis, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery and the disease has been stable for at least 3 months without steroid use or on a stable dose of steroids for at least 1 month prior to starting study drug. stability of brain metastases must be confirmed with imaging. * the patient has a concurrent, active hematological malignancy or other solid tumor malignancy. * history of clinically significant cardiac or pulmonary dysfunction. * allergy or hypersensitivity to components of the gsk1120212 formulation. * the patient is pregnant or breastfeeding.
learning through play (ltp) in my own way plus cbt

Conditions: Intellectual Disability; Depression

Summary: aim of the study is to evaluate the acceptability and feasibility of ltp in my own way plus with depressed mothers of id children.

having a child with a chronic medical problem or an intellectual disability increases anxiety and depression in parents. there is some growing evidence that families of id children are able to meet the challenges. the purpose of the present study is to adapt ltp in my own way plus to test its acceptability and determine if it improves mothers knowledge about their child development and reduce their level of distress. the study has two phases: quantitative phase and qualitative phase. quantitative phase: a single blind randomised controlled trial in school settings in karachi pakistan. objectives: 1. help mothers cope better with their depression. 2. teach mothers play activities that will stimulate their children's development and improve mother-child interaction. qualitative phase: this will help to determine acceptability of the intervention and identify perceived mechanisms of change and any barriers and facilitators to ltp in my own plus intervention. in-depth digitally recorded interviews and focus groups will be conducted with the parents and teachers to understand their beliefs, views, and feelings about caring for id children.

Eligibility criteria:
inclusion criteria: * mothers of id children aged 3 to 6 years, screened positive for depression * ability to complete a baseline assessment * ability to communicate in urdu or english exclusion criteria: * have a diagnosed serious medical or psychiatric condition * mothers of children with other medical illness * temporary residents unlikely to be available for follow-up
lumbar disc space height in young disc herniation and degeneration patients

Conditions: Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Low Back Pain

Summary: as low back pain (lbp) imposes a heavy socioeconomic burden, early detection of pathologic intervertebral disc change in young adults holds high clinical relevance as a common structural cause of lbp. the investigators therefore assessed the feasibility of using x-ray disc space height measurements as a predictive evaluation method of lumbar disc herniation (ldh) and degeneration in lbp patients in their early 20s.


Eligibility criteria:
inclusion criteria: * age 20-25 years * l-spine x-ray and l-spine mris taken within a week of the other test * native korean ethnicity exclusion criteria: * scoliosis with a cobb's angle of ≥20° * significant vertebral deformity of any etiology (e.g. spondylolisthesis, fracture, spondylitis, neoplasm) * previous spinal surgery

Keywords: x-rays magnetic resonance imaging sensitivity and specificity
a study to investigate the pharmacokinetics, safety, and tolerability of subcutaneous ocrelizumab administration in participants with multiple sclerosis

Conditions: Multiple Sclerosis (MS)

Summary: this study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (ms).


Eligibility criteria:
inclusion criteria: * diagnosis of primary progressive multiple sclerosis (ppms) or relapsing multiple sclerosis (rms) according to the revised mcdonald 2017 criteria (thompson et al. 2018) * expanded disability status scale (edss) score, 0-6.5, inclusive, at screening * absence of relapses for 30 days prior to the screening visit * for the dose escalation phase for participants pretreated with ocrelizumab (group a): treatment with iv ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks) * for women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab. * for female perticipants without reproductive potential: women may be enrolled if post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy). exclusion criteria: * ms disease duration of more than 15 years for participants with an expanded disability status scale (edss) score \<2.0 at screening. * known presence of other neurologic disorders that may mimic ms, including, but not limited to, the following: * history of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord * history or known presence of central nervous system (cns) or spinal cord tumor (e.g., meningioma,glioma) * history or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin b12 deficiency) * history or known presence of infectious causes of myelopathy (e.g., syphilis, lyme disease, human t-lymphotropic virus 1, herpes zoster and myelopathy. * history of genetically inherited progressive cns degenerative disorder (e.g., hereditary paraparesis and mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke syndrome) * neuromyelitis optica * history or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, sjögren syndrome, behçet disease, sarcoidosis). * history of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression
comparison of auto-adjusting positive airway pressure devices

Conditions: Obstructive Sleep Apnea

Summary: little is understood about how different auto-adjusting pap devices operate. the purpose of this evaluation is to compare two devices in a randomised two night psg trial.


Eligibility criteria:
inclusion criteria: * males aged ≥ 18 years * recently diagnosed with osa (ahi ≥15). recently defined as less than 3 months before study entry * naive to cpap therapy * participants willing and able to give written informed consent exclusion criteria: * participants requiring bi-level pap * participants requiring supplemental oxygen * participants who are pregnant * subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: copd, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
p53 synthetic long peptides vaccine with cyclophosphamide for ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to determine whether the addition of cyclophosphamide to the treatment with the p53-slp vaccine improves clinical efficacy and immunogenicity of the p53-slp vaccine in ovarian cancer patients.


Eligibility criteria:
inclusion criteria: * written informed consent. * histological proven epithelial ovarian carcinoma. * at least 4 weeks after termination of the last course of chemotherapy. * rising ca-125 serum levels after "first line" treatment and no measurable disease according to the recist (response evaluation criteria in solid tumours) criteria, or rising ca-125 serum levels after "first line" treatment with measurable disease according to the recist (response evaluation criteria in solid tumours) criteria, but not willing or otherwise not fit to receive "second line" chemotherapy. * age 18 years or older, and an life expectancy of at least 3 months. * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. * performance status 0 to 2 (who scale). * adequate hepatic, renal, and bone marrow function as defined: asat \ 3.0 x 109/l; platelets \> 100 x 109/l; hemoglobin \> 6.0 mmol/l. - adequate venous access for blood collection and i.v. administration of cyclophosphamide. exclusion criteria: * pregnancy and / or breast feeding. * (a)symptomatic cystitis. * other malignancies (previous or current), except basal or squamous cell carcinoma of the skin. * immunosuppressive agents, except for topical and inhalation corticosteroids. * prior therapy with a biological response modifier. * any other major disease that may interfere with the conduct of the study (e.g. uncontrolled hypertension, severe and/or unstable heart disease, neurological and psychiatric disorders). * signs or symptoms of cns metastases. * known substance abuse (drug or alcohol).

Keywords: ovarian cancer patients with recurrent disease
e-intervention on subclinical fear of cancer recurrence

Conditions: Cancer; Psychooncology; Fear of Cancer Recurrence

Summary: the present study aims to adapt a metacognition-based conquerfear-hk to an internet-based self-management intervention, namely econquerfear-hk and evaluate in a randomised controlled trial, its feasibility, utility, and potential effectiveness on fear of cancer recurrence reduction among local chinese cancer survivors with subclinical fear of cancer recurrence.

a pilot randomised controlled feasibility trial will used to test the feasibility, utility, and potential effectiveness of an internet-based self-management intervention for fear of cancer recurrence among local chinese cancer survivors with subclinical fear of cancer recurrence. the following hypotheses will be tested: 1. there will be a greater fcr improvement in cancer survivors receiving econquerfear-hk intervention vs those in the active control group. 2. there will be a greater mcq reduction in cancer survivors receiving econquerfear-hk intervention vs those in the active control group. 3. there will be greater improvements in secondary outcomes (psychological distress and quality of life) in cancer survivors receiving econquerfear-hk intervention vs those in the active control group. 4. cancer survivors receiving econquerfear-hk intervention will perceive the intervention useful for managing their fcr and be satisfied with the intervention. 5. cancer survivors receiving econquerfear-hk intervention will show high completion rates.

Eligibility criteria:
inclusion criteria: * cantonese- or mandarin-speaking chinese cancer survivors * recently diagnosed with potentially curable (stage 0 to iii) colorectal or breast cancer * had recently completed surgery as primary treatment * have completed hospital-based adjuvant treatments (including radiotherapy and chemotherapy) within the past six months * scored 13 to 21 on the fear of cancer recurrence-short form will be recruited. exclusion criteria: * non-chinese ethnicity * metastatic cancer * with current diagnosis of depression or psychosis or are currently receiving psychological treatments * language or intellectual difficulties that prevent them from understanding the intervention content * having limited or no internet access.
transitioning from cyclosporine to alefacept in psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.

the purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept. patients in the study are well controlled on cyclosporine and desire to switch to alefacept. the study is done in three phases. in phase 1 (12 week duration) the two drugs will be overlapped, with cyclosporine slowly tapering. both drugs will be discontinued after 12 weeks. in phase 2 (12 weeks duration), patients are off both drugs. in phase 3 (24 weeks long), patients are on a second course of alefacept alone for 12 weeks and then off for 12 weeks. topical and uv light treatments are allowed throughout the study. total length of study is one year.

Eligibility criteria:
inclusion criteria * adult psoriasis patients (18 to 80 years old), who are well controlled on cyclosporine (static pga score of mild, minimal or clear) and who need or desire to stop cyclosporine and start alefacept. exclusion criteria * cd4 \<400 * active infection (other than trivial uri, etc.) * history of aids or hepatitis b, c * inability to understand consent or comply with study requirements * pregnancy or lactation * history of heart or liver disease

Keywords: psoriasis cyclosporine transition alefacept
duloxetine on bone metabolism

Conditions: Chronic Pain; Fibromyalgia

Summary: the aim of the study was to determine the effect of duloxetine as monotherapy on biochemical markers and bone mineral density.

51 patients diagnosed with chronic pain or fibromyalgia syndrome who were using duloxetine for at least 3 months and age and sex matched 51 healthy individuals were recruited for this cross-sectional study. bone mineral density of both groups were measured by dual energy x ray absorbsiometry(dxa), bone biochemical markers, serum calcium, and vitamin d levels were investigated.

Eligibility criteria:
inclusion criteria: * \>18 years or \<50 years * patients using duloxetine for at least 3 months due to chronic pain or fibromyalgia exclusion criteria: * postmenopausal women * clinical conditions which cause secondary osteoporosis * patients using medication that cause secondary osteoporosis * pregnancy and malignity

Keywords: duloxetine chronic pain fibromyalgia bone metabolism
psychophysiologic predictors of post-deployment mental health outcomes

Conditions: Post-traumatic Stress Disorder

Summary: the primary objectives of this proposal are to develop objective pre-deployment predictors of ptsd and test two pre-deployment resiliency interventions.

the primary objectives of this proposal are to develop objective pre-deployment predictors of ptsd and test two pre-deployment resiliency interventions. the objective predictors will be based on: 1) physiologic reactivity (heart rate, heart rate variability, eye blink startle, skin conductance) to virtual reality (vr) environments depicting common operation iraqi freedom (oif) or operation enduring freedom (oef) combat scenarios and 2) cognitive bias assessment using a recognition memory paradigm. we hypothesize that a model combining physiologic reactivity and cognitive bias predictors will be superior to either the physiologic reactivity or cognitive bias model alone for predicting post-deployment ptsd. we also will test two pre-deployment resiliency interventions: heart rate variability biofeedback and cognitive bias modification training that we have designed to target physiologic and cognitive responses to stress, respectively. we will compare the prevention interventions to a no intervention control group. we hypothesize that the prevalence of post-deployment ptsd will be lower in the intervention groups compared to the control group.

Eligibility criteria:
inclusion criteria: * army national guard members who are scheduled to deploy for oif/oef operations within the next 12 months, age 18 to 60, and willing to provide the name and phone number of at least one person to help locate the member for the follow-up assessments if necessary. exclusion criteria: * implantable pacemaker or cardiac defibrillator * unable to wear a virtual reality headset

Keywords: post-traumatic stress disorder post-deployment prediction prevention
rabeprazole extended release 50 mg versus ranitidine 150 mg for maintenance of healed erosive gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (egerd).

this is a multicenter, randomized, double-blind, double-dummy, parallel-group study. subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily). please note that this study is not a duplicate of e3810-g000-305; this is a separate study being conducted along with -305.

Eligibility criteria:
key inclusion criteria: 1. prior completion of study e3810-g000-302 or -303. subjects will need to have healed erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by egd and sustained resolution of heartburn at visit 4 or 5 of study e3810-g000-302 or -303. key exclusion criteria: 1. esophageal motility disorders (achalasia, scleroderma, or esophageal spasm). 2. barrett's esophagus or esophageal stricture. 3. use of prescription or non-prescription proton pump inhibitors (ppis), histamine receptor antagonists (h2ra), antacids, sucralfate, misoprostol, prokinetics or drugs with significant anticholinergic effects throughout the study. 4. subjects who require chronic use of nonsteroidal anti-inflammatory drugs (nsaids), oral steroids (\>= 20 mg/day prednisone or equivalent), or aspirin (-\>; 325 mg/day). 5. significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would be likely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study. 6. any condition that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study.

Keywords: gastroesophageal reflux disease gerd
drug utilization prevalence in a pediatric care medical center

Conditions: Infectious Diseases; Metabolic Diseases; Cancer

Summary: one year prospective analysis of drug utilization and prescription point prevalence of medications in a pediatric tertiary care university medical center. off-label use of medications in the study population will be also registered.


Eligibility criteria:
inclusion criteria: * all admitted children receiving at least one prescribed or otc medication. exclusion criteria: * all admitted children who do not get a prescribed or otc medication.

Keywords: prescription point prevalence drug utilization define daily dose
comparing rezum and urolift

Conditions: Prostate Cancer

Summary: this is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (rezum) arm or prostatic urethral lift (urolift) arm.


Eligibility criteria:
inclusion criteria: * male ≥ 50 years symptomatic bph international prostate symptom score (ipss) ≥13 prostate volume 30-80ml exclusion criteria: * history or high suspicion of prostate cancer * current urinary tract infection * refractory urinary retention or post-void residual (pvr) ≥250 ml * intravesical prostatic protrusion (ipp)\>10mm * prior prostate surgery * known or suspected allergy to nickel, titanium, or polyester/polypropylene * urethral stricture, meatal stenosis, bladder neck contracture * neurogenic bladder and/or sphincter abnormalities